US2022289812A1PendingUtilityA1

Elp fusion proteins comprising parathyroid hormone for controlled and sustained release

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Assignee: PHASEBIO PHARMACEUTICALS INCPriority: Aug 9, 2019Filed: Aug 7, 2020Published: Sep 15, 2022
Est. expiryAug 9, 2039(~13.1 yrs left)· nominal 20-yr term from priority
Inventors:David J. BallanceJames Jowett
A61K 38/00C07K 14/78A61K 9/0019C07K 14/635A61K 38/39A61K 38/29A61P 19/00A61P 19/10
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Claims

Abstract

The present disclosure provides novel pharmaceutical compositions comprising a parathyroid hormone or a parathyroid hormone related protein and an elastin-like peptide. These pharmaceutical compositions provide sustained, long-lasting control of serum calcium levels, and may be used in treating osteoporosis and hypoparathyroidism.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A pharmaceutical composition comprising a parathyroid hormone (PTH) or a parathyroid hormone related protein (PTHrP) and an elastin-like peptide, wherein the elastin-like peptide (ELP) comprises repeating units of any one of SEQ ID NOs: 1-13. 
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the PTH is a full-length PTH (SEQ ID NO: 14). 
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein the PTH is a truncated PTH. 
     
     
         4 . The pharmaceutical composition of  claim 3 , wherein the PTH is truncated at the C-terminus. 
     
     
         5 . The pharmaceutical composition of  claim 4 , wherein the PTH is PTH(1-34) (SEQ ID NO: 16) or PTH(1-32) (SEQ ID NO: 18). 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the PTHrP is a full-length PTHrP. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the PTHrP is a truncated PTHrP. 
     
     
         8 . The pharmaceutical composition of  claim 7 , wherein the PTHrP is truncated at the C-terminus. 
     
     
         9 . The pharmaceutical composition of  claim 8 , wherein the PTHrP is PTHrP (1-32). 
     
     
         10 . The pharmaceutical composition of  claim 1 , wherein the ELP comprises structural repeats of SEQ ID NO: 3. 
     
     
         11 . The pharmaceutical composition of  claim 10 , wherein X is independently selected from valine, glycine, and alanine. 
     
     
         12 . The pharmaceutical composition of  claim 11 , wherein X is independently selected from V, G and A at a ratio of 5:3:2. 
     
     
         13 . The pharmaceutical composition of  claim 10 , wherein X is independently selected from valine and alanine. 
     
     
         14 . The pharmaceutical composition of  claim 13 , wherein X is independently selected from valine and alanine at a ratio of 6:3. 
     
     
         15 . The pharmaceutical composition of any of  claims 1  to  14 , wherein the ELP comprises at least 90 repeating structural units. 
     
     
         16 . The pharmaceutical composition of  claim 15 , wherein the ELP comprises at least 120 repeating structural units. 
     
     
         17 . The pharmaceutical composition of  claim 16 , wherein the ELP comprises the amino acid sequence of SEQ ID NO: 34. 
     
     
         18 . The pharmaceutical composition of  claim 16 , wherein the ELP comprises at least 144 repeating structural units. 
     
     
         19 . The pharmaceutical composition of  claim 18 , wherein the ELP comprises the amino acid sequence of SEQ ID NO: 35. 
     
     
         20 . The pharmaceutical composition of any of  claims 1  to  18 , wherein the PTH or PTHrP and ELP are in a fusion protein. 
     
     
         21 . The pharmaceutical composition of  claim 20 , wherein the fusion protein is selected from:
 a) SEQ ID NO: 20;   b) SEQ ID NO: 22;   c) SEQ ID NO: 24;   d) SEQ ID NO: 26;   e) SEQ ID NO: 28; and   f) SEQ ID NO: 30.   
     
     
         22 . A method of increasing serum calcium levels in a subject comprising administering to a subject in need thereof the pharmaceutical composition of any one of  claims 1 - 21 . 
     
     
         23 . A method of increasing bone formation in a subject, comprising to a subject in need thereof administering the pharmaceutical composition of any one of  claims 1  to  21 . 
     
     
         24 . A method of reducing bone absorption in a subject, comprising administering to a subject in need thereof the pharmaceutical composition of any one of  claims 1  to  21 . 
     
     
         25 . A method of treating, ameliorating, or delaying osteoporosis, comprising administering to a subject in need thereof the pharmaceutical composition of any one of  claims 1  to  21 . 
     
     
         26 . A method of treating, ameliorating, or delaying hypoparathyroidism, comprising administering to a subject in need thereof the pharmaceutical composition of any one of  claims 1  to  21 . 
     
     
         27 . The method of any of  claims 22  to  26 , wherein the pharmaceutical composition is administered subcutaneously. 
     
     
         28 . The method of any of  claims 22  to  27 , wherein the pharmaceutical composition is administered daily or weekly.

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